The Council of Ministers adopted a new piece of chemicals legislation REACH on 18th October 2006 that was also approved of by the European Parliament in the course of its second reading on 13th December. REACH Regulation was published on December 30th 2006 in the Official Journal of the European Union, entering into force on July 1st 2007. Relevant revision of REACH Regulation was published on May 29th 2007 in the Official Journal of the European Union.
The primary purpose of the new chemicals legislation REACH (Registration, Evaluation and Authorization of Chemicals) is to improve the protection of human health and the environment against risks associated with use of chemicals. REACH has put into place a system both for “new” and “existing” chemicals.
REACH in brief:
1. REACH encompasses all chemicals (both hazardous and non-hazardous) except for those that are explicitly beyond its scope.
2. Registration calls upon manufacturers and importers of chemicals (of 1 tone of more per annum) to collect required information on chemicals. This information allows for safe use of chemicals as well as for drafting risk reduction measures. Data collection requirements depend on volumes of manufactured/imported chemicals (groups: 1-10 tone, 10-100 tone, 100-1000 tone and over 1000 tone). Registration dossier has to be provided directly to the European Chemicals Agency (ECHA) that has been set up together with REACH’s entry into force, and is based in Helsinki. This system will provide for rapidly acquiring a lot of chemicals information that have so far not been appropriately available. What is more, producers and importers of chemicals are liable to pre-register their substances (applicable for volumes of and over 1 tone per annum). Pre-registration has to be carried out between June 1st and December 1st 2008.
3. Evaluation consists of registration dossier evaluation and substance evaluation. . The ECHA will check the compliance of the registration dossiers with the requirements laid down for registration in Regulation, in addition to checking testing proposals. On substance evaluation, the ECHA, in cooperation with relevant Member States competent authorities, will develop guidance on the prioritization of certain substances for further evaluation. Industry, on the other hand, will make relevant analyses of chemical safety. In doing so, responsibility for risk assessment has been lifted off Member States’ competent authorities‘shoulders, and rather placed on those of industry.
4. Authorization is a procedure within REACH dealing with substances of high concern (e.g. PBT-persistent, bioaccumulative and toxic substances) that require special supervision. Both producers and downstream users may be granted authorization whereby they have to take into consideration whether any appropriate and safer alternative substances and technologies are in place for substitution. Provided that such substances and technologies are available as well as being technically and economically viable, relevant substitution plans have to be formulated. Otherwise relevant information on activities regarding development and research of securing safer alternatives need to be provided. A major aim of authorization is to have all substances progressively substituted by safer alternatives.
5. REACH puts significant emphasis on reducing animal testing with the result that those liable to register their chemicals have to share data collected from vertebrate testing. What is more, alternative testing methods are being encouraged as well.
6. REACH improves a flow of information on properties of dangerous substances, risks and risk reduction measures in the supply chain both upstream and downstream. This means that also downstream users of chemicals are part and parcel of this system (ranging from formulators of preparations to manufacturers of products and end users) when it comes to drafting chemical safety assessments and taking into consideration risk reduction recommendations.
7. Restrictions of and bans on placing on the market certain hazardous substances present a “safety net”, an instrument that the EU uses to manage risks for substances that would otherwise not be appropriately controlled.
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